Responding to partial lead failure in an implantable cardioverter defibrillator

CROSS REFERENCE TO RELATED APPLICATIONS

0001This application is a divisional of U.S. patent application Ser. No. 11/433,541, filed May 12, 2006, is now U.S. Pat. No. 7,747,320.

BACKGROUND

00021. Field of the Invention

0003The present invention relates generally to implantable cardioverter defibrillators (ICDs) and, more particularly, to preserving ICD functionality in the event of lead failure.

00042. Background Art

0005An implantable cardiac device is a medical device that is implanted in a patient to monitor electrical activity of a heart and to deliver appropriate electrical and/or drug therapy, as required. Implantable cardiac devices include, for example, pacemakers, cardioverters, defibrillators, and the like. The term “implantable cardioverter defibrillator” or simply “ICD” is used hereinafter to refer to any implantable cardiac device.

0006The ICD includes one or more electrodes that interact with the heart. Before delivering a signal to the heart from the ICD via the electrodes, it is desirable to first check the state of a signal path to determine, for example, if a low impedance or short-circuit like condition exists. A short-circuit like condition can be caused by an electrode touching a housing of the ICD, possibly due to rubbing between the electrode and the housing that has damaged the electrode insulation; two electrodes touching because insulating material between them has worn through; subclavicular crushing of electrodes against each other; displacement or dislodgement of an electrode; and from other situations. Typically, if a short-circuit like condition exists in the signal path, conventional devices either switch to a different electrode configuration (in an effort to find a non short-circuit signal path) or simply stop delivery of the therapy signal to the heart (to prevent damage to the ICD output circuitry). There are times, however, when an effective, alternate lead configuration is not available. Furthermore, failing to deliver therapy can be problematic if the therapy signal was required to sustain a patient's life.

0007What is needed is a system and method that overcomes deficiencies of known systems.

SUMMARY

0008An implanted cardioverter defibrillator (ICD) delivers an electrical therapy signal to the heart of a patient. When ventricular fibrillation or another condition of the heart requiring high voltage therapy is sensed, the therapy signal (i.e., an electrical shocking pulse) is delivered to the heart. When a partial short-circuit or other low impedance condition occurs, an over-current protection circuit will stop delivery of the shocking pulse. The ICD will then reduce the voltage of the shocking pulse and try again to deliver electrical therapy. This process is repeated until a voltage level is found that is able to deliver the electrical therapy without causing an over-current condition. Alternate lead configurations may also be tried in an attempt to find a signal path that is not affected by the low impedance or short-circuit condition.

0009Further features, as well as the structure and operation of various embodiments are described in detail below with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS/FIGURES

0010The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate various embodiments and, together with the description, further serve to explain the principles of the embodiments and to enable a person skilled in the relevant art to make and use the embodiments.

0011<figref idref="DRAWINGS">FIG. 1</figref> is a diagram illustrating an ICD in electrical communication with at least three leads implanted into a patient's heart for delivering multi-chamber stimulation and shock therapy.

0012<figref idref="DRAWINGS">FIG. 2</figref> is a block diagram of an ICD that can provide cardioversion, defibrillation and pacing stimulation in four chambers of a heart.

0013<figref idref="DRAWINGS">FIG. 3</figref> is a flowchart illustrating operation of an ICD according to one embodiment.

0014<figref idref="DRAWINGS">FIG. 4</figref> is an extension of the flowchart of <figref idref="DRAWINGS">FIG. 3</figref>, illustrating an alternate embodiment.

0015The various embodiments will now be described with reference to the accompanying drawings. In the drawings, like reference numbers may indicate identical or functionally similar elements.

DETAILED DESCRIPTION

0016The following detailed description refers to the accompanying drawings that illustrate exemplary embodiments. Other embodiments are possible, and modifications may be made to the embodiments. Therefore, the following detailed description is not meant to limit. Rather, the scope of the invention is limited only by the appended claims.

0017It will be apparent to one of skill in the art that the one or more embodiments, as described below, may be implemented in many different embodiments of hardware, software, and/or firmware. Any actual software and/or hardware described herein is not limiting of the one or more embodiments. Thus, the operation and behavior of the one or more embodiments will be described with the understanding that modifications and variations of the embodiments are possible, given the level of detail presented herein.

0018Before describing the one or more embodiments in detail, it is helpful to describe an example environment. The present embodiments are useful in the environment of an implantable cardiac device (ICD) as described below.

0019As shown in <figref idref="DRAWINGS">FIG. 1</figref>, an exemplary ICD <b>10</b> is in electrical communication with a patient's heart <b>12</b> by way of three leads, <b>20</b>, <b>24</b> and <b>30</b>, suitable for delivering multi-chamber stimulation and pacing therapy, according to one embodiment. To sense atrial cardiac signals and to provide right atrial chamber stimulation therapy, ICD <b>10</b> is coupled to implantable right atrial lead <b>20</b> having at least an atrial tip electrode <b>22</b>, which typically is implanted in the patient's right atrial appendage.

0020To sense left atrial and ventricular cardiac signals and to provide left-chamber pacing therapy, ICD <b>10</b> is coupled to “coronary sinus” lead <b>24</b> designed for placement in the “coronary sinus region” via the coronary sinus for positioning a distal electrode adjacent to the left ventricle and/or additional electrode(s) adjacent to the left atrium. As used herein, the phrase “coronary sinus region” refers to the vasculature of the left ventricle, including any portion of the coronary sinus, great cardiac vein, left marginal vein, left posterior ventricular vein, middle cardiac vein, and/or small cardiac vein or any other cardiac vein accessible by the coronary sinus.

0021Accordingly, exemplary coronary sinus lead <b>24</b> is designed to receive atrial and ventricular cardiac signals and to deliver left ventricular pacing therapy using at least a left ventricular tip electrode <b>26</b>, left atrial pacing therapy using at least a left atrial ring electrode <b>27</b>, and shocking therapy using at least a left atrial coil electrode <b>28</b>.

0022ICD <b>10</b> is also shown in electrical communication with the patient's heart <b>12</b> by way of an implantable right ventricular (RV) lead <b>30</b> having, in this embodiment, a right ventricular tip electrode <b>32</b>, a right ventricular ring electrode <b>34</b>, a right ventricular coil electrode <b>36</b>, and a superior vena cava (SVC) coil electrode <b>38</b>. Typically, right ventricular lead <b>30</b> is transvenously inserted into heart <b>12</b> so as to place the right ventricular tip electrode <b>32</b> in the right ventricular apex so that RV coil electrode <b>36</b> will be positioned in the right ventricle and SVC coil electrode <b>38</b> will be positioned in the superior vena cava. Accordingly, right ventricular lead <b>30</b> is capable of receiving cardiac signals and delivering stimulation in the form of pacing and shock therapy to the right ventricle.

0023<figref idref="DRAWINGS">FIG. 2</figref> shows a block diagram of ICD <b>10</b>, which is capable of treating both fast and slow arrhythmias with stimulation therapy, including cardioversion, defibrillation, and pacing stimulation, according to one embodiment. While a particular multi-chamber stimulation device is shown, it is shown for illustration purposes only, and one of skill in the art could readily duplicate, eliminate or disable the appropriate circuitry in any desired combination to provide a device capable of treating the appropriate chamber(s) with the desired cardioversion, defibrillation and pacing stimulation.

0024A housing <b>40</b> of ICD <b>10</b>, shown schematically in <figref idref="DRAWINGS">FIG. 2</figref>, is often referred to as the “can,” “case,” or “case electrode” and may be programmably selected to act as the return electrode for all “unipolar” modes. Housing <b>40</b> may further be used as a return electrode alone or in combination with one or more of coil electrodes, <b>28</b>, <b>36</b>, and <b>38</b> for shocking purposes. Housing <b>40</b> further includes a connector (not shown) having a plurality of terminals, <b>42</b>, <b>44</b>, <b>46</b>, <b>48</b>, <b>52</b>, <b>54</b>, <b>56</b>, and <b>58</b> (shown schematically and, for convenience, the names of the electrodes to which they are connected are shown next to the terminals). As such, to achieve right atrial sensing and pacing, the connector includes at least a right atrial tip terminal (AR TIP) <b>42</b> adapted for connection to atrial tip electrode <b>22</b>.

0025To achieve left chamber sensing, pacing and shocking, the connector includes at least a left ventricular tip terminal (VL TIP) <b>44</b>, a left atrial ring terminal (AL RING) <b>46</b>, and a left atrial shocking terminal (AL COIL) <b>48</b>, which are adapted for connection to left ventricular ring electrode <b>26</b>, left atrial tip electrode <b>27</b>, and left atrial coil electrode <b>28</b>, respectively.

0026To support right chamber sensing, pacing, and shocking the connector also includes a right ventricular tip terminal (VR TIP) <b>52</b>, a right ventricular ring terminal (VR RING) <b>54</b>, a right ventricular shocking terminal (RV COIL) <b>56</b>, and an SVC shocking terminal (SVC COIL) <b>58</b>, which are configured for connection to right ventricular tip electrode <b>32</b>, right ventricular ring electrode <b>34</b>, RV coil electrode <b>36</b>, and SVC coil electrode <b>38</b>, respectively.

0027At the core of ICD <b>10</b> is a programmable microcontroller <b>60</b>, which controls the various modes of stimulation therapy. As is well known in the art, microcontroller <b>60</b> typically includes a microprocessor, or equivalent control circuitry, designed specifically for controlling the delivery of stimulation therapy and can further include RAM or ROM memory, logic and timing circuitry, state machine circuitry, I/O circuitry, and the like. Typically, microcontroller <b>60</b> includes the ability to process or monitor input signals (data) as controlled by a program code stored in a designated block of memory. The details of the design of microcontroller <b>60</b> are not critical. Rather, any suitable microcontroller <b>60</b> can be used to carry out the functions described herein. The use of microprocessor-based control circuits for performing timing and data analysis functions are well known in the art.

0028Representative types of control circuitry that may be used include the microprocessor-based control system of U.S. Pat. No. 4,940,052 (Mann et. al.) and the state-machines of U.S. Pat. No. 4,712,555 (Thornander et al.) and U.S. Pat. No. 4,944,298 (Sholder). For a more detailed description of the various timing intervals used within the ICD's and their inter-relationship, see U.S. Pat. No. 4,788,980 (Mann et. al.). The '052, '555, '298 and '980 patents are incorporated herein by reference in their entireties.

0029As shown in <figref idref="DRAWINGS">FIG. 2</figref>, an atrial pulse generator <b>70</b> and a ventricular pulse generator <b>72</b> generate pacing stimulation pulses for delivery by right atrial lead <b>20</b>, right ventricular lead <b>30</b>, and/or coronary sinus lead <b>24</b> via an electrode configuration switch <b>74</b>. It is understood that in order to provide stimulation therapy in each of the four chambers of the heart, atrial and ventricular pulse generators <b>70</b> and <b>72</b> may include dedicated, independent pulse generators, multiplexed pulse generators, or shared pulse generators. Pulse generators <b>70</b> and <b>72</b> are controlled by microcontroller <b>60</b> via appropriate control signals <b>76</b> and <b>78</b>, respectively, to trigger or inhibit the stimulation pulses.

0030Microcontroller <b>60</b> further includes timing control circuitry <b>79</b>, which is used to control pacing parameters (e.g., the timing of stimulation pulses) as well as to keep track of the timing of refractory periods, PVARP intervals, noise detection windows, evoked response windows, alert intervals, marker channel timing, etc., which are well known in the art. Examples of pacing parameters include, but are not limited to, atrio-ventricular (AV) delay, interventricular (RV-LV) delay, atrial interconduction (A-A) delay, ventricular interconduction (V-V) delay, and pacing rate.

0031Switch <b>74</b> includes a plurality of switches for connecting the desired electrodes to the appropriate I/O circuits, thereby providing complete electrode programmability. Accordingly, switch <b>74</b>, in response to a control signal <b>80</b> from microcontroller <b>60</b>, determines the polarity of the stimulation pulses (e.g., unipolar, bipolar, combipolar, etc.) by selectively closing the appropriate combination of switches (not shown) as is known in the art.

0032Atrial sensing circuits <b>82</b> and ventricular sensing circuits <b>84</b> may also be selectively coupled to right atrial lead <b>20</b>, coronary sinus lead <b>24</b>, and right ventricular lead <b>30</b>, through switch <b>74</b> for detecting the presence of cardiac activity in each of the four chambers of the heart. Accordingly, the atrial (ATR. SENSE) and ventricular (VTR. SENSE) sensing circuits <b>82</b> and <b>84</b> may include dedicated sense amplifiers, multiplexed amplifiers, or shared amplifiers. Switch <b>74</b> determines the “sensing polarity” of the cardiac signal by selectively closing the appropriate switches, as is also known in the art. In this way, a clinician may program the sensing polarity independent of the stimulation polarity.

0033Each sensing circuit, <b>82</b> and <b>84</b>, preferably employs one or more low power, precision amplifiers with programmable gain and/or automatic gain control, bandpass filtering, and a threshold detection circuit, as known in the art, to selectively sense the cardiac signal of interest. The automatic gain control enables ICD <b>10</b> to deal effectively with the difficult problem of sensing the low amplitude signal characteristics of atrial fibrillation (AF) or ventricular fibrillation (VF). Such sensing circuits, <b>82</b> and <b>84</b>, can be used to determine cardiac performance values.

0034The outputs of atrial and ventricular sensing circuits <b>82</b> and <b>84</b> are connected to microcontroller <b>60</b> which, in turn, are able to trigger or inhibit atrial and ventricular pulse generators, <b>70</b> and <b>72</b>, respectively, in a demand fashion in response to the absence or presence of cardiac activity, in the appropriate chambers of the heart. Sensing circuits <b>82</b> and <b>84</b>, in turn, receive control signals over signal lines <b>86</b> and <b>88</b> from microcontroller <b>60</b> for purposes of measuring cardiac performance at appropriate times, and for controlling the gain, threshold, polarization charge removal circuitry (not shown), and timing of any blocking circuitry (not shown) coupled to the inputs of sensing circuits <b>82</b> and <b>86</b>.

0035For arrhythmia detection, ICD <b>10</b> utilizes the atrial and ventricular sensing circuits <b>82</b> and <b>84</b> to sense cardiac signals to determine whether a rhythm is physiologic or pathologic. The timing intervals between sensed events (e.g., P-waves, R-waves, and depolarization signals associated with fibrillation) are then classified by microcontroller <b>60</b> by comparing them to a predefined rate zone limit (i.e., bradycardia, normal, low rate VT, high rate VT, and fibrillation rate zones) and various other characteristics (e.g., sudden onset, stability, physiologic sensors, and morphology, etc.) in order to determine the type of remedial therapy that is needed (e.g., bradycardia pacing, anti-tachycardia pacing, cardioversion shocks or defibrillation shocks, collectively referred to as “tiered therapy”).

0036Microcontroller <b>60</b> utilizes arrhythmia detection circuitry <b>75</b> and morphology detection circuitry <b>76</b> to recognize and classify arrhythmia so that appropriate therapy can be delivered.

0037Cardiac signals are also applied to the inputs of an analog-to-digital (A/D) data acquisition system <b>90</b>. Data acquisition system <b>90</b> is configured to acquire intracardiac electrogram signals, convert the raw analog data into a digital signal, and store the digital signals for later processing and/or telemetric transmission to an external device <b>102</b>. Data acquisition system <b>90</b> is coupled to right atrial lead <b>20</b>, coronary sinus lead <b>24</b>, and right ventricular lead <b>30</b> through switch <b>74</b> to sample cardiac signals across any pair of desired electrodes.

0038Data acquisition system <b>90</b> can be coupled to microcontroller <b>60</b>, or other detection circuitry (not shown), for detecting an evoked response from heart <b>12</b> in response to an applied stimulus, thereby aiding in the detection of “capture.” Capture occurs when an electrical stimulus applied to the heart is of sufficient energy to depolarize the cardiac tissue, thereby causing the heart muscle to contract. Microcontroller <b>60</b> detects a depolarization signal during a window following a stimulation pulse, the presence of which indicates that capture has occurred. Microcontroller <b>60</b> enables capture detection by triggering ventricular pulse generator <b>72</b> to generate a stimulation pulse, starting a capture detection window using timing control circuitry <b>79</b> within microcontroller <b>60</b>, and enabling data acquisition system <b>90</b> via control signal <b>92</b> to sample the cardiac signal that falls in the capture detection window and, based on the amplitude, determines if capture has occurred.

0039The implementation of capture detection circuitry and algorithms are well known. See for example, U.S. Pat. No. 4,729,376 (Decote, Jr.); U.S. Pat. No. 4,708,142 (Decote, Jr.); U.S. Pat. No. 4,686,988 (Sholder); U.S. Pat. No. 4,969,467 (Callaghan et al.); and U.S. Pat. No. 5,350,410 (Mann et al.), which patents are hereby incorporated herein by reference. The type of capture detection system used is not critical.

0040Microcontroller <b>60</b> is further coupled to a memory <b>94</b> by a suitable data/address bus <b>96</b>, wherein the programmable operating parameters used by microcontroller <b>60</b> are stored and modified, as required, in order to customize the operation of ICD <b>10</b> to suit the needs of a particular patient. Such operating parameters define, for example, pacing pulse amplitude, pulse duration, electrode polarity, rate, sensitivity, automatic features, arrhythmia detection criteria, and the amplitude, waveshape and vector of each shocking pulse to be delivered to the patient's heart <b>12</b> within each respective tier of therapy.

0041The operating parameters of ICD <b>10</b> may be non-invasively programmed into memory <b>94</b> through a telemetry circuit <b>100</b> in telemetric communication with external device <b>102</b>, such as a programmer, transtelephonic transceiver, or a diagnostic system analyzer. Telemetry circuit <b>100</b> is activated by microcontroller <b>60</b> by a control signal <b>106</b>. Telemetry circuit <b>100</b> can allow intracardiac electrograms and status information relating to the operation of ICD <b>10</b> (as contained in microcontroller <b>60</b> or memory <b>94</b>) to be sent to external device <b>102</b> through an established communication link <b>104</b>. Communication link <b>104</b> can be wired or wireless depending on a particular application, and both are contemplated.

0042For examples of such devices, see U.S. Pat. No. 4,809,697, entitled “Interactive Programming and Diagnostic System for use with Implantable Pacemaker” (Causey, III et al.); U.S. Pat. No. 4,944,299, entitled “High Speed Digital Telemetry System for Implantable Device” (Silvian); and U.S. Pat. No. 6,275,734, entitled “Efficient Generation of Sensing Signals in an Implantable Medical Device such as a Pacemaker or ICD” (McClure et al.), which patents are hereby incorporated herein by reference.

0043In one embodiment, ICD <b>10</b> further includes a physiologic sensor <b>108</b> that can be used to detect changes in cardiac performance or changes in the physiological condition of the heart. Accordingly, microcontroller <b>60</b> can respond by adjusting the various pacing parameters (such as rate, AV Delay, RV-LV Delay, V-V Delay, etc.) in accordance with the embodiments. Microcontroller <b>60</b> controls adjustments of pacing parameters by, for example, controlling the stimulation pulses generated by the atrial and ventricular pulse generators <b>70</b> and <b>72</b>. While shown as being included within ICD <b>10</b>, it is to be understood that physiologic sensor <b>108</b> may also be external to ICD <b>10</b>, yet still be implanted within or carried by the patient. More specifically, sensor <b>108</b> can be located inside ICD <b>10</b>, on the surface of ICD <b>10</b>, in a header of ICD <b>10</b>, or on a lead (which can be placed inside or outside the bloodstream).

0044ICD <b>10</b> further includes a magnet detection circuitry (not shown), coupled to microcontroller <b>60</b>. The magnet detection circuitry detects the presence of a magnet placed outside the patient's body over ICD <b>10</b>. A clinician may use the magnet to perform various test functions of ICD <b>10</b> and/or to signal microcontroller <b>60</b> that external device <b>102</b> is in place to receive or transmit data to microcontroller <b>60</b> through telemetry circuit <b>100</b>.

0045As further shown in <figref idref="DRAWINGS">FIG. 2</figref>, ICD <b>10</b> is shown as having an impedance measuring circuit <b>112</b>, which is enabled by microcontroller <b>60</b> via a control signal <b>114</b>. For example, impedance can be measured as discussed in commonly owned U.S. Pat. No. 6,658,294 and in commonly owned, co-pending U.S. patent application Ser. No. 11/188,278, filed Jul. 21, 2005, which are incorporated herein by reference. Uses for an impedance measuring circuit <b>112</b> include, but are not limited to, lead impedance surveillance during the acute and chronic phases for proper lead positioning or for detecting dislodgement; detecting operable electrodes and automatically switching to an operable pair if dislodgement occurs; measuring respiration or minute ventilation; measuring thoracic impedance for determining shock thresholds; detecting when the device has been implanted; measuring stroke volume; and detecting the opening of heart valves. The impedance measuring circuit <b>112</b> can be coupled to switch <b>74</b> so that any desired electrode may be used.

0046In the case where ICD <b>10</b> is intended to operate as a cardioverter, pacer or defibrillator, it must detect the occurrence of an arrhythmia and automatically apply an appropriate electrical therapy to the heart aimed at terminating the detected arrhythmia. To this end, microcontroller <b>60</b> further controls a shocking circuit <b>116</b> (e.g., a signal generator) by way of a control signal <b>118</b>. The shocking circuit <b>116</b> generates shocking pulses (e.g., signals or therapy signals) of low (e.g., up to about 0.5 joules), moderate (about 0.5 to about 10 joules), or high energy (about 11 to about 40 joules), as controlled by microcontroller <b>60</b>. Such shocking pulses are applied to the patient's heart <b>12</b> through at least two shocking electrodes (e.g., selected from left atrial coil electrode <b>28</b>, RV coil electrode <b>36</b>, and SVC coil electrode <b>38</b>). As noted above, housing <b>40</b> may act as an active electrode in combination with RV electrode <b>36</b>, or as part of a split electrical vector using SVC coil electrode <b>38</b> or left atrial coil electrode <b>28</b> (i.e., using the RV electrode as a common electrode).

0047Cardioversion shocks are generally considered to be of low to moderate energy level (so as to minimize pain felt by the patient), and/or synchronized with an R-wave and/or pertaining to the treatment of tachycardia. Defibrillation shocks are generally of moderate to high energy level (i.e., corresponding to thresholds in the range of 5-40 joules), delivered asynchronously (since R-waves may be too disorganized to be recognized), and pertaining exclusively to the treatment of fibrillation. Accordingly, microcontroller <b>60</b> is capable of controlling the synchronous or asynchronous delivery of the shocking pulses.

0048ICD <b>10</b> additionally includes a first power system <b>110</b> (e.g., a battery), which provides operating power to a load that includes most of the circuits shown in <figref idref="DRAWINGS">FIG. 2</figref>. Because ICD <b>10</b> employs shocking therapy, battery <b>110</b> must be capable of operating at low current drains for long periods of time, and then be capable of providing high-current pulses (for capacitor charging) when the patient requires a shock pulse. Because the lower current drains occur over much longer periods of time than the higher current drains, the lower current drains typically account for a significant portion of battery <b>110</b> consumption. Elective replacement time of battery <b>110</b> may be determined by monitoring the level of battery <b>110</b> depletion. Battery <b>110</b> may be a lithium/silver vanadium oxide battery but other battery chemistries can also be used.

0049In the event of an arrhythmic event such as ventricular fibrillation (VF), it is desired to immediately provide shocking therapy to defibrillate the heart. However, as discussed above, it is undesirable to deliver a large shocking pulse into leads that are short-circuited together. Impedance measuring circuit <b>112</b> can be used to measure the impedance of a particular lead configuration prior to delivery of a shock. Such monitoring can be used to find both short-circuits and open-circuits.

0050In addition to using impedance measuring circuit <b>112</b> to monitor the impedance between a particular electrode combination, an over-current protection circuit <b>83</b> is used to protect shocking circuit <b>116</b> and electrically configurable switch <b>74</b> from damage caused by delivering high voltage shocking pulse into short-circuited leads. For example, over-current protection circuit <b>83</b> can monitor the current being delivered to the leads and stop current deliver (i.e., open the circuit) if the current exceeds a preset value, such as 40 amperes. The over-current protection circuit can detect the over-current condition and stop current flow in, for example, about 100 microseconds. This quick response will prevent any damage to ICD <b>10</b>.

0051In <figref idref="DRAWINGS">FIG. 2</figref>, over-current protection circuit <b>83</b> is shown as being part of switch <b>74</b>. In another example, over-current protection circuit <b>83</b> can be part of shocking circuit <b>116</b>. Such over-current protection circuits are known and would be apparent to a person skilled in the relevant arts.

0052As discussed above, upon detection of a short-circuit condition, known ICD's either switch to a different lead configuration (in an attempt to find non-short-circuited leads) or simply fail to deliver the required shocking therapy. Alternate lead configurations, however, may not be available or may not be as effective in delivering the required electrical therapy. Furthermore, failing to deliver a required electrical therapy can be problematic.

0053To overcome these limitations, ICD <b>10</b> includes voltage reduction circuitry <b>81</b>. Voltage reduction circuitry <b>81</b> is shown in <figref idref="DRAWINGS">FIG. 2</figref> as being part of micro-controller <b>60</b>. Voltage reduction circuitry <b>81</b> may be implemented in software, firmware, hardware or any combination thereof. Furthermore, voltage reduction circuitry <b>81</b> can be part of microcontroller <b>60</b>, a separate functional block of ICD <b>10</b> or may be, for example, part of shocking circuit <b>116</b>.

0054In the event that over-current protection circuit <b>83</b> detects an over-current condition, circuit <b>83</b> will stop full delivery of the electrical pulse to the selected leads. Thereafter, voltage reduction circuit <b>81</b> will attempt to find a reduced voltage of the therapy signal that will avoid an over-current condition but still deliver effective therapy to the heart.

0055Finding a reduced voltage that will not result in an over-current condition is premised on the fact that many seemingly “short-circuit” conditions are actually caused by low conductor spacings at either thin or nonexistent insulation that are not total or complete short-circuits. That is, the impedance (resistance) of the signal path through the selected lead/electrode configuration is high until a critical “arc-over” voltage is presented. For example, subclavicular crushing or rubbing between an electrode and the ICD housing or between two leads can damage the electrode insulation, causing a lower than normal spacing (e.g., a “conditional” short-circuit) but not causing a continuous short-circuit. In these cases of less than normal spacing or insulation, a shocking pulse at a high voltage (e.g., 870 volts) may cause an over current condition, while a shocking pulse at a lower voltage (e.g., 470 volts) may not cause an over current condition. If a therapeutically effective shocking pulse can be delivered using a lower voltage, then a good result has been achieved. In some cases, the lower voltage pulse could result in defibrillation of a heart that otherwise might not receive the required therapy.

0056Example operation of voltage reduction circuitry <b>81</b> of ICD <b>10</b> is illustrated in a method <b>300</b> shown in the flowchart of <figref idref="DRAWINGS">FIG. 3</figref>. Referring to <figref idref="DRAWINGS">FIG. 3</figref>, an arrhythmia, such as ventricular fibrillation (VF), is sensed by ICD <b>10</b> as indicated at step <b>302</b>. ICD <b>10</b> then determines that shocking therapy is required to treat the VF. In a step <b>304</b>, capacitors within ICD <b>10</b> are charged to a relatively high voltage (V_M) in order to store the energy required to deliver the required shock. For example, two series connected capacitors in shocking circuit <b>116</b> are charged to a total of 870 volts.

0057In step <b>306</b>, shocking circuit <b>116</b> delivers the shocking pulse to the selected lead electrodes via switch <b>74</b>. If over-current protection circuit <b>83</b> senses an over-current condition at step <b>308</b>, then circuit <b>83</b> will terminate delivery of the full shocking pulse (e.g., circuit <b>83</b> can respond in about one (1) microsecond). The method then proceeds to step <b>312</b>.

0058At step <b>312</b>, the voltage on the capacitors is adjusted to a smaller voltage magnitude. For example, in the case where the capacitors were charged to 870 volts and an over-current condition was detected before the full charge was delivered, the majority of the charge will still remain on the capacitors. Therefore, the capacitors may need to be further discharged to achieve a smaller voltage magnitude. For example, the capacitors could be discharged (as necessary) to a value of 770 volts, 100 volts less than the full charge value. In other instances, it may be necessary to charge the capacitors to achieve the desired voltage magnitude. In one embodiment, the method could then proceed directly to step <b>306</b>, where shocking circuit <b>116</b> delivers the reduced-voltage shocking pulse to the selected lead electrodes. In another embodiment, optional steps <b>314</b> and <b>316</b> may be performed.

0059Step <b>314</b> is performed substantially in parallel with step <b>312</b>. That is, while the voltage on the capacitors is adjusted in step <b>312</b>, ATP (anti-tachycardia pacing) therapy is delivered at step <b>314</b>. The ATP therapy may use the currently selected electrode configuration or may use a different electrode configuration. For example, this can include biventricular ATP with various schemas and can also include ATP between large electrodes. Use of ATP therapy to treat VF is premised on the observation that oftentimes an indicated VF is actually tachycardia. Next, once step <b>312</b> is complete, a check is made at step <b>316</b> to determine whether VF is still present. If VF is no longer present, the method proceeds to step <b>310</b>.

0060Returning to step <b>308</b>, if no over-current condition is sensed at step <b>308</b>, then the method proceeds to step <b>310</b>. At step <b>310</b>, the voltage across the capacitors (V_M) is stored. The assumption is that, since the voltage V_Mdid not result in an over-current condition, the value of V_Mis the maximum voltage that can be delivered without causing an over-current condition.

0061In method <b>300</b>, steps <b>306</b>-<b>316</b> may be performed in an iterative manner. For example, an initial 870 volt shocking pulse may cause an over-current condition (steps <b>306</b> and <b>308</b>). The voltage on the capacitors may then be reduced to 770 volts (step <b>312</b>) and another shock delivered at step <b>306</b>. If this 770 volts pulse again causes an over-current condition (step <b>308</b>), the voltage can be reduced to 670 volts (step <b>312</b>) and another shock delivered. If the 670 Volt shock does not cause an over-current condition, then the 670 Volt value can be saved (step <b>310</b>) as a value that will not cause an over-current condition. The method can then return to step <b>302</b> where it will end if VF is no longer present. However, if VF is present, the capacitors can be charged to the stored 670 Volt value, and another shock can be delivered.

0062In one embodiment of the invention, the capacitor voltage (V_M) is decreased in steps of about 100 volts. In another embodiment, the capacitor voltage is decreased in steps of about 10 volts. It will be apparent to a person skilled in the art that various other voltage steps sizes can be used, including values between 10 volts and 100 volts. It will also be apparent to a person skilled in the art that large steps will result in a method that will more quickly execute, and that smaller steps will allow ICD <b>10</b> to more closely identify the actual value of the voltage that avoids an over-current condition (if such a voltage exists). The actual voltage step size is a design choice depending on a variety of factors and may be programmably selected via an external programmer <b>102</b>. In one alternative embodiment, a binary search is used to quickly determine the highest safe voltage.

0063<figref idref="DRAWINGS">FIG. 4</figref> shows an alternate embodiment of method <b>300</b> shown in <figref idref="DRAWINGS">FIG. 3</figref>. In this alternate embodiment, steps <b>402</b>-<b>408</b> are added into method <b>300</b> between steps <b>308</b> and <b>312</b>/<b>314</b>. In this alternate embodiment, after an over-current condition is sensed in step <b>308</b>, the method proceeds to step <b>402</b>. In step <b>402</b>, an “offending” electrode (i.e., the electrode that is believed to have contributed to the short-circuit condition) is switched out of the signal path. In other words, a new electrode configuration is selected. Switching the “offending” electrode out of the signal path can be done with one or more methods as described in commonly owned, co-pending U.S. patent application Ser. No. 11/188,278. For example, if the shock of step <b>306</b> was delivered to the heart via a path that uses RV coil electrode <b>56</b> as the anode and case <b>40</b> as the cathode, then case <b>40</b> could be replaced with a different electrode, such as SVC coil electrode <b>58</b>. Switching the electrode configuration in this manner may remove the low-impedance condition that tripped over-current protection circuit <b>83</b>. Thereafter, the method proceeds to step <b>404</b>.

0064In a step <b>404</b>, shocking circuit <b>116</b> delivers a shocking pulse (e.g., at a full capacitor voltage or at a reduced voltage V_M) to the selected lead electrodes via switch <b>74</b>. In a step <b>406</b>, it is determined whether the shock was successful in terminating the VF. If VF is no longer present, then the method returns to step <b>302</b> to monitor for further arrhythmias. If VF is still present, the therapy delivered via the new lead configuration was not successful, so the method proceeds to step <b>408</b> where the original, offending lead configuration is reselected. The method then proceeds to steps <b>312</b> and <b>314</b> as described above.

0065In yet another embodiment of the invention, step <b>408</b> can be omitted, and method <b>300</b> can proceed using the newly selected electrode configuration. In yet another embodiment, method <b>300</b> can proceed (without steps <b>402</b>-<b>408</b>) until the voltage V_Mis reduced to a predetermined minimum voltage (e.g., 200 volts) without finding a voltage that would not cause an over-current condition. Thereafter, step <b>402</b> could be performed to select an alternate electrode configuration. Method <b>300</b> could then be repeated using the alternate electrode configuration.

0066Example embodiments of the methods, systems, and components of the have been described herein. As noted elsewhere, these example embodiments have been described for illustrative purposes only, and are not intended to limit the scope of the present invention. Other embodiments are possible. Such embodiments will be apparent to persons skilled in the relevant art(s) based on the teachings contained herein. Thus, the breadth and scope of the invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

0067It is to be appreciated that the Detailed Description section, and not the Summary and Abstract sections, is intended to be used to interpret the claims. The Summary and Abstract sections may set forth one or more but not all exemplary embodiments of the present invention as contemplated by the inventor(s), and thus, are not intended to limit the present invention and the appended claims in any way.